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When Public Citizen’s Health Research Group writes about drugs, we often, in addition to other sources, refer to the drug label approved by the Food and Drug Administration (FDA) when discussing evidence of risks or benefits. But what is a drug label? The answer is not as obvious as it seems.
Drugs often arrive in the hands of consumers accompanied by many different types of written instructions, including writing on the packages, information sheets from the pharmacy or patient guides...
When Public Citizen’s Health Research Group writes about drugs, we often, in addition to other sources, refer to the drug label approved by the Food and Drug Administration (FDA) when discussing evidence of risks or benefits. But what is a drug label? The answer is not as obvious as it seems.
Drugs often arrive in the hands of consumers accompanied by many different types of written instructions, including writing on the packages, information sheets from the pharmacy or patient guides placed inside the drug’s packaging by a manufacturer.
Yet these materials are unlikely to include the official professional label, which the FDA has reviewed. Instead, patients routinely receive an unofficial, non-FDA-approved information leaflet, sometimes referred to as a patient information leaflet. These leaflets are unregulated, and they often do not meet the FDA’s standards for usefulness or scientific accuracy.[1]
Professional labels, by contrast, are scientifically accurate and highly regulated, but they are written in technical language and intended to be read by health professionals. Moreover, they traditionally have been accessible mainly through publications targeted at doctors and nurses. That is now changing, and consumers are now increasingly able to access professional labels directly online.
The details found in a drug’s professional label can be useful to patients, but are sometimes hard to understand. Also, some parts of the label may be more helpful than others. Knowledge about these drug labels can be an important tool for consumers seeking to improve their health while avoiding drug-induced injuries.
Finding FDA-approved professional drug labels
The government resource that is probably the easiest for consumers to use is DailyMed (dailymed.nlm.nih.gov). DailyMed offers a database that can be searched by a drug’s brand name or active ingredient.
For consumers without a computer, you can ask your pharmacist for a copy of the FDA-approved “package insert,” but he or she may not have a copy available, and many pharmacists routinely will provide a non-FDA-approved patient information leaflet instead. As an alternative, consumers can view, download and print the label directly using public computers at the library (or by asking a friend or relative with a computer). To print a label, click on the text “OFFICIAL LABEL (PRINTER FRIENDLY)” near the top of each drug’s webpage at DailyMed.
Searching DailyMed often yields multiple listings for the same drug, and not all of them are up to date. You can check how old a label is by looking at the date it was last updated, which can be found on the top right of the drug’s DailyMed webpage, or at the bottom of the first or last page of the printed label.
Here are some of the most important sections to read in a drug’s professional label.
Black-box warnings
The most important part of a drug’s label is the warning that sometimes appears in a box at the top (sometimes called the “boxed warning” or “black-box warning”). The FDA requires such warnings on certain drugs in order to highlight serious risks that are important enough to lead health care professionals to consider not prescribing the drug for certain patients or to prescribe it only after taking precautions to reduce the risk of side effects.[2]
Indications and usage
Another important section of the label is titled “Indications and Usage.” This section describes the use, or indication, for which the FDA has reviewed and approved the drug. For example, the label for the drug bevacizumab (AVASTIN) explains that it is used to treat specific types of cancer.[3],[4]
| Beware ‘Off-Label’ Drug Uses |
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Sometimes health care professionals will prescribe a drug “off label,” for a use that has not been approved by the Food and Drug Administration (FDA). Using a drug off-label is inherently risky, because the drug has not been reviewed by the FDA for evidence that it is effective, safe and sold in a form that is appropriate for the off-label use. Sometimes, after rigorous testing, drugs prove ineffective for off-label uses. For example, bevacizumab (AVASTIN) was prescribed off-label for breast cancer for years.[5] Approved for other cancers, the drug often was used by oncologists to treat breast cancer based on early studies suggesting benefit.[6] But subsequent high-quality studies showed that the drug was not beneficial enough for breast cancer to justify its serious risks, leading the FDA in 2011 to deliberately exclude this type of cancer from the indications section of the drug’s label.[7] Safety risks also may be greater with off-label uses, as reported in the January issue of Worst Pills, Best Pills News: A recent study found that patients receiving prescriptions for off-label uses were more likely to stop the drugs due to an adverse reaction than people getting the drugs for approved uses. In addition, off-label use without strong scientific evidence supporting that use was more dangerous than off-label use with such evidence.[8] When your doctor prescribes a new medicine, ask if it is approved for treating your disease. If the drug is for an off-label use, talk to your doctor about the scientific evidence supporting the use and whether FDA-approved alternatives are available. |
Contraindications, warnings and precautions
Other sections of the professional drug label provide additional important information about a drug’s serious risks.
The “Contraindications” section describes patients who should not use the product at all because of serious risks. For example, the blood-thinning drug warfarin (COUMADIN, JANTOVEN) generally is contraindicated in pregnant women, because it can cause birth defects and fetal bleeding.[9]
The “Warnings” and “Precautions” sections describe serious side effects that could result in death, life-threatening side effects, hospitalization, long-term disability or birth defects, or are otherwise important enough to potentially affect treatment decisions.[10]
Adverse reactions
The section of the label titled “Adverse Reactions” includes a lengthy list of less serious but potentially common drug side effects. Common symptoms, such as insomnia or constipation, may be listed in this section even if there is only weak evidence that the drug causes the symptoms.[11]
Tables in this section can show how often a particular symptom occurred in clinical testing. If a symptom was much more common among subjects taking the drug than among those taking a placebo, it is more likely that the drug was responsible for that side effect. (Generally, however, clinical trials do not involve enough subjects to confirm that the drug causes the side effect with statistical certainty.) For example, in clinical testing for venlafaxine (EFFEXOR XR), nausea was 10 times more common in patients taking the drug than in those taking a placebo — strong evidence that the drug is associated with nausea.[12]
| Medication Guides for Patients |
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| Some Food and Drug Administration-approved drugs have official Medication Guides intended for patients that simplify and summarize important information about the drug. Unfortunately, pharmacists often face challenges obtaining these guides and distributing them with every prescription.[13] A list of drugs with medication guides, and links to printable versions, is published at: bit.do/medicationguides. |
Other sections
FDA-approved professional drug labels also have separate sections summarizing scientific data, including information from animal testing and additional data from clinical trials in humans. This information can be useful to readers with a scientific background, but the sections may be difficult to understand for many consumers.
What You Can Do
If you are taking a prescription drug, chances are you have not yet read its professional label. Keep yourself better informed by visiting DailyMed to download the label or by asking for a copy of the FDA-approved label at the pharmacy. Also, talk to your health care provider about any concerning information you discover.
References
[1] Public Citizen. Testimony on the status of written prescription drug information for consumers. July 31, 2003. http://www.citizen.org/Page.aspx?pid=3248. Accessed April 21, 2016.
[2] Food and Drug Administration. Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products – content and format. October 2011. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075096.pdf. Accessed March 21, 2016.
[3] DailyMed. Label: Avastin-bevacizumab injection, solution. Updated December 3, 2015. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e. Accessed March 21, 2016.
[4] Ziemssen F, Grisanti S, Bartz-Schmidt KU, Spitzer MS. Off-label use of bevacizumab for the treatment of age-related macular degeneration: What is the evidence? Drugs Aging. 2009;26(4):295-320. http://www.ncbi.nlm.nih.gov/pubmed/19476398. Accessed March 21, 2016.
[5] Hamel S, McNair DS, Birkett NJ, et al. Off-label use of cancer therapies in women diagnosed with breast cancer in the United States. Springerplus. 2015;4:209. doi: 10.1186/s40064-015-0981-z. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4422830/
[6] National Cancer Institute. FDA approval for bevacizumab. Updated December 4, 2014. http://www.cancer.gov/about-cancer/treatment/drugs/fda-bevacizumab. Accessed April 1, 2016.
[7] Ibid.
[8] New evidence that off-label drug use increases risk of harm. Worst Pills, Best Pills News. January 2016. /newsletters/view/1006. Accessed March 21, 2016.
[9] DailyMed. Label: warfarin sodium – warfarin sodium tablet. Updated October 25, 2011. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=558b7a0d-5490-4c1b-802e-3ab3f1efe760. Accessed March 21, 2016.
[10] Food and Drug Administration. Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products – content and format. October 2011. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075096.pdf. Accessed March 21, 2016.
[11] Ibid.
[12] DailyMed. Label: Effexor XR – venlafaxine hydrochloride capsule, extended release. Updated October 29, 2015. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26. Accessed March 21, 2016.
[13] National Community Pharmacists Association. Use of medication guides to distribute drug risk information to patients. June 13, 2007. http://www.fda.gov/downloads/drugs/drugsafety/ucm173478.pdf.
